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Clinical Study of TBF Regimen in Allo-HSCT in Patients With CNS Leukemia

Primary Purpose

Central Nervous System Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation

Status

Not yet recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

TBF regimen

modified BuCY2 regimen

About this trial

This is an interventional treatment trial for Central Nervous System Leukemia

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients diagnosed with central nervous system leukemia by MICM meet one of the following conditions: corresponding symptoms and signs of central nervous system involvement; cerebrospinal fluid pressure increased by 200 mm water column; the white blood cell count in cerebrospinal fluid was 0.01×10^9/L; cerebrospinal fluid protein qualitative test was positive or protein quantification was 45 mg/dL; leukemic cells can be found in the cerebrospinal fluid; cranial imaging suggested central involvement. Aged 14-60 years, male or female. KPS score: ≥80. Signed the informed consent. Exclusion Criteria: Patients intending to receive autologous hematopoietic stem cell transplantation. Patients with transplantation contraindications. Those who refuse to sign the informed consent form.

Sites / Locations

First Affiliated Hospital of Xi'an Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TBF group

Modified BuCY2 group

Arm Description

The subjects receive TBF conditioning regimen.

The subjects receive modified BuCY2 conditioning regimen.

Outcomes

Primary Outcome Measures

Recurrence rate of central nervous system (CNS) leukemia

The proportion of patients with recurrent central nervous system leukemia in the total enrolled population

Secondary Outcome Measures

Hematopoietic implantation rate

Hematopoiesis was achieved within 100 days after allo-HSCT

NRM

non-recurrence mortality

overall survival

PFS

progression-free survival

AEs

adverse effects

Full Information

NCT ID

NCT05667402

First Posted

October 27, 2022

Last Updated

December 26, 2022

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

1. Study Identification

Unique Protocol Identification Number

NCT05667402

Brief Title

Clinical Study of TBF Regimen in Allo-HSCT in Patients With CNS Leukemia

Official Title

Clinical Study of TBF Regimen in Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Central Nervous System Leukemia

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

January 15, 2023 (Anticipated)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Central nervous system (CNS) leukemia is a poor prognostic factor for allogeneic hematopoietic stem cell transplantation (allo-HSCT). Thiotepa can penetrate the blood-brain barrier and has immunosuppressive effects and similar effects to irradiation in allo-HSCT. This project aims to investigate whether the TBF regimen is superior to the traditional modified BuCY2 regimen to improve the long-term survival of the CNS leukemia patients.

Detailed Description

Central nervous system (CNS) leukemia is a common extramedullary leukemia and a poor prognostic factor for allogeneic hematopoietic stem cell transplantation (allo-HSCT). There is a blood-brain barrier (BBB) in the CNS. The treatment effect of CNS leukemia is seriously limited by the low penetration of conventional chemotherapy drugs into cerebrospinal fluid. Thiotepa can penetrate the BBB and has immunosuppressive effect and myeloablative effect similar to irradiation in transplantation. Therefore, it is speculated that cestipide has certain advantages as a conditioning regimen in transplantation for CNS leukemia. This project aims to investigate whether the TBF regimen is superior to the traditional modified BuCY2 regimen to improve the long-term survival of the CNS leukemia patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Central Nervous System Leukemia, Allogeneic Hematopoietic Stem Cell Transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TBF group

Arm Type

Experimental

Arm Description

The subjects receive TBF conditioning regimen.

Arm Title

Modified BuCY2 group

Arm Type

Active Comparator

Arm Description

The subjects receive modified BuCY2 conditioning regimen.

Intervention Type

Drug

Intervention Name(s)

TBF regimen

Other Intervention Name(s)

Conditioning treatment with TBF regimen

Intervention Description

The subjects receive TBF conditioning regimen (Thiotepa, Busulfan, Fludarabine) before allo-HSCT.

Intervention Type

Drug

Intervention Name(s)

modified BuCY2 regimen

Other Intervention Name(s)

Conditioning treatment with modified BuCY2 regimen

Intervention Description

The subjects receive modified BuCY2 conditioning regimen (Busulfan, Cytarabine, ATG, Cyclophosphamide, CCNU) before allo-HSCT.

Primary Outcome Measure Information:

Title

Recurrence rate of central nervous system (CNS) leukemia

Description

The proportion of patients with recurrent central nervous system leukemia in the total enrolled population

Time Frame

From date of the treatment with the conditioning regimen until CNS leukemia relapse, the end of follow-up or the date of death from any cause, whichever came first, assessed up to 36 months.

Secondary Outcome Measure Information:

Title

Hematopoietic implantation rate

Description

Hematopoiesis was achieved within 100 days after allo-HSCT

Time Frame

From date of the treatment with the conditioning regimen until hematopoietic implantation, assessed up to 100 days..

Title

NRM

Description

non-recurrence mortality

Time Frame

From date of allo-HSCT until the date of death from any cause or the end of follow-up, whichever came first, assessed up to 36 months.

Title

Description

overall survival

Time Frame

From date of the treatment with the conditioning regimen until the end of follow-up or the date of death from any cause, whichever came first, assessed up to 36 months.

Title

PFS

Description

progression-free survival

Time Frame

From date of the treatment with the conditioning regimen until leukemia progression, the end of follow-up or the date of death from any cause, whichever came first, assessed up to 36 months.

Title

AEs

Description

adverse effects

Time Frame

From date of the treatment with the conditioning regimen until the occurrence of adverse effects, the end of follow-up or the date of death from any cause, whichever came first, assessed up to 36 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pengcheng He, MD

Phone

0086-85324035

hepc@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaoyan Zheng, MD

Phone

0086-15829370502

xiaoy_2008@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pengcheng He, MD

Organizational Affiliation

First Affiliated Hospital of Xian Jiaotong University

Official's Role

Principal Investigator

Facility Information:

Facility Name

First Affiliated Hospital of Xi'an Jiaotong University

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710061

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pengcheng He, MD

Phone

0086-85324035

hepc@163.com

12. IPD Sharing Statement

Learn more about this trial

Clinical Study of TBF Regimen in Allo-HSCT in Patients With CNS Leukemia

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